Biosimilars/follow-on-biologics global market expected to reach US$35bn by 2020
Led by monoclinal antibodies, erythropoietin and granulocyte colony-stimulating factor biosimilars
The global biosimilars market is expected to increase to US$35bn by 2020 from an estimated $1.3bn in 2013, according to a new report from Portland, Oregon, US-based market research company Allied Market Research.
Deeper penetration with clearer regulatory pathways in developed markets and higher efficacy and safety in emerging markets will support growth during the forecast period.
The report, Global biosimilars/follow-on-biologics market (types, applications and geography) – Size, Share, Global Trends, Company Profiles, Demand, Insights, Analysis, Research, Report, Opportunities, Segmentation and Forecast, 2013–2020, finds that more than 10 blockbuster biologics with annual sales of $60bn are facing patent expiry in Europe and the US over the next four years. Top pharmaceutical manufacturing brands are therefore repositioning their strategic agendas from approvals to product launches to gain market capitalisation.
'Biosimilars developers have been using emerging markets with less intellectual property protection as their launch pad for established markets,' say AMR analysts.
'With the regulatory framework maturing in established markets, it will be easier for biosimilars manufacturers to enter into such markets quickly,' they add, citing collaboration between Mylan and Biocon to commercialise a biosimilar of trastuzumab in India and the approval of the first biosimilar version of a monoclonal antibody drug by Hospira (Inflectra) in Europe.
Biosimilars to treat cancer are currently dominating the market
Owing to lower intellectual property rights protection and higher activity of regional players, the Asia-Pacific region has emerged as the leader in the biosimilars market, the report finds.
Strategic collaborations for global expansion, especially for segments with high potential, such as monoclonal antibodies (mAbs) and erythropoietin, will be key to market growth, the report finds. However, such strategies are persistently threatened by traditional patent infringements.
Granulocyte colony-stimulating factor biosimilars will follow erythropoietin in terms of revenue generation during the forecast period.
Biosimilars to treat cancer are currently dominating the market, but biosimilars for chronic and autoimmune diseases and blood disorders are the fastest-growing applications and will show marked growth during the analysis period.
Key biosimilars developers such as Novartis (Sandoz), Synthon Pharmaceuticals, Teva Pharmaceutical Industries, LG Life Sciences, Celltrion, Biocon, Hospira, Merck Serono, Biogen idec, and Genentech have adopted approval and clinical trials as key developmental strategies to gain a competitive edge in the pharmaceuticals market. These firms are also focusing on adhering to regulatory guidelines to expand in the world markets.
